Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults
- Registration Number
- NCT06153758
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- 18 years or older and overtly healthy
- Body mass Index (BMI) between 16-32 kg/m2; and a total body weight >50 kg (110 lb)
Exclusion Criteria
- Evidence or history of clinically significant medical conditions or laboratory abnormality
- Any condition possibly affecting drug absorption
- Known intolerance/hypersensitivity to a GLP-1 R agonist
- Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A Danuglipron Participants will receive a single oral dose of danuglipron on Day 1 of each period Part D Danuglipron Participants will receive a single oral dose of danuglipron on Day 1 of each period Part B Danuglipron Participants will receive a single oral dose of danuglipron on Day 1 of each period Part C Danuglipron Participants will receive a single oral dose of danuglipron on Day 1 of each period
- Primary Outcome Measures
Name Time Method Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state Predose to 48 hours post danuglipron administration Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state Predose to 48 hours post danuglipron administration Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state Predose to 48 hours post danuglipron administration Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state Predose to 48 hours post danuglipron administration Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state Predose to 48 hours post danuglipron administration Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state Predose to 48 hours post danuglipron administration
- Secondary Outcome Measures
Name Time Method All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities From baseline up to 28-35 days post last dose taken All Parts: Number of Participants reporting Treatment Emergent Adverse Events From baseline up to 28-35 days post last dose taken All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities From baseline up to 28-35 days post last dose taken All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state Predose to 48 hours post danuglipron administration All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities From baseline up to 28-35 days post last dose taken All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state Predose to 48 hours post danuglipron administration All Parts: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fed state Predose to 48 hours post danuglipron administration
Trial Locations
- Locations (1)
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States